What are the responsibilities and job description for the Clinical Research QA Manager position at Actalent?
Clinical Research QA Manager
Must have Clinical Research industry experience
Must have management experience
Manage a team of clinical QA personnel while also conducting both internal and external audits within GCP guidelines
Conducts clinical site audits (domestic and international) verifying regulatory compliance and protocol compliance
Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations
Reviews clinical audit reports and provides guidance to auditors
Supports inspection readiness program
Serves as a subject matter expert for quality
Promotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System
Hosts client audits, conducts external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigations
Supports regulatory authority inspection
Qualifications
Must have management/supervision experience (minimum of 2 -3 years)
Understanding and working knowledge of GCP (minimum 5 years)
Experience working with eQMS
Travel 10-20% (domestic and international). 1 domestic trip every other month. 1 international trips per year
Minimum a B.S/B.A., Certified Quality Auditor (CQA) preferred, advanced degree preferred
Pay and Benefits
The pay range for this position is $52.88 - $62.50
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $53 - $63
